Bone anchor receiver with extension portions having controlled splay allowance helically wound flange forms

ABSTRACT

Open implant closure structures include a helically wound guide and advancement flange form having splay control surfaces. Multi-start closures and closures with inner set screws have splay control contours for interlocking with cooperating flange forms of bone anchor receivers. Flange form heights, thicknesses and other geometry, such as splay control ramp angle may be varied.

CROSS-REFERENCE TO RELATED APPLICATIONS

This continuation application claims priority under 35 U.S.C. § 120 fromU.S. application Ser. No. 15/689,080 entitled “HELICAL FLANGE WITH STARTSTRUCTURE AND SPLAY ALLOWANCE TO CLOSE AND LOCK OPEN BONE ANCHORRECEIVERS,” filed Aug. 29, 2017, which is a continuation of U.S.application Ser. No. 14/567,217 entitled “SPLAY CONTROL CLOSURE FOR OPENBONE ANCHOR,” filed on Dec. 11, 2014, now U.S. Pat. No. 9,770,265 issuedSep. 26, 2017, which is a continuation of U.S. application Ser. No.14/086,728 entitled “SPLAY CONTROL CLOSURE FOR OPEN BONE ANCHOR,” filedNov. 21, 2013, now U.S. Pat. No. 8,911,478 issued Dec. 16, 2014 whichclaims the benefit of priority under 35 U.S.C. § 119 from U.S.Provisional Patent Application No. 61/796,859 entitled “SPLAY CONTROLCLOSURE FOR OPEN BONE ANCHOR,” filed Nov. 21, 2012 and U.S. ProvisionalPatent Application No. 61/851,300 entitled “SPLAY CONTROL CLOSURE FOROPEN BONE ANCHOR,” filed Mar. 5, 2013. Each of these applications isfully incorporated by reference herein in its entirety for all purposes.

BACKGROUND OF THE INVENTION

The present invention is directed to structure for joining togetherparts of a medical implant, in particular for use with open bone anchorsin spinal surgery, and in some embodiments thereof, for use with spinalbone anchors such as polyaxial screws.

Bone anchors, such as bone screws and hooks are utilized in many typesof spinal surgery in order to secure various implants to vertebrae alongthe spinal column for the purpose of stabilizing and/or adjusting spinalalignment. For example, the most common mechanism for providingvertebral support is to implant bone screws into certain bones whichthen in turn support a longitudinal connecting member, such as a rod, orare supported by the connector. Although both closed-ended andopen-ended bone anchors are known, open-ended anchors are particularlywell suited for connections to longitudinal connecting members such ashard, soft or deformable rods, dynamic, soft or elastic connectors andconnector sleeves or arms, because such rods or other connector membersdo not need to be passed through a closed bore, but rather can be laidor urged into an open channel within a receiver or head of such a boneanchor. Generally, the anchors must be inserted into the bone as anintegral unit or a preassembled unit, in the form of a shank or hook andconnected pivotal receiver. In some instances, a portion of such apreassembled unit, such as a shank of a polyaxial bone screw assembly,may be independently implanted into bone, followed by push- or pop-onassembly of a receiver portion of the unit that includes the openchannel for receiving a rod or other longitudinal connecting member.

Typical open-ended bone screws include a threaded shank with a head orreceiver having a pair of parallel projecting branches or arms whichform a yoke with a U-shaped slot or channel to receive a portion of arod or other longitudinal connecting member. Hooks and other types ofconnectors, as are used in spinal fixation techniques, may also includesimilar open ends for receiving rods or portions of other fixation andstabilization structure. After the rod or other longitudinal connectingmember is placed in the receiver channel, a closure, typically in theform of a substantially cylindrical plug is often used to close thechannel. Known closures include slide-on types, twist-on varieties thatare rotated ninety degrees to a locked in position, and a variety ofsingle start helically wound guide and advancement structures including,for example, thread forms having v-thread, reverse-angle, buttress orsquare thread forms, to name a few, as well as other non-threadlikehelically wound forms.

It is known that the angled loading flank of a v-thread closuregenerates outward splay of spaced open implant receiver arms at allloading levels without limit. Thus, v-threaded closures or plugs aresometimes used in combination with outer threaded nuts that preventoutward splaying of the receiver arms. To overcome the splay problems ofv-threaded closures, so-called “buttress” thread forms were developed.In a buttress thread, the trailing or thrust surface is linear andoriented somewhat downwardly in the direction of advancement withrespect to the thread axis, while the leading or clearance surface isangled rearwardly in varying degrees, theoretically resulting in aneutral radial reaction of a threaded receptacle or receiver to torqueon the threaded closure member being received thereby. In reverse angledthread forms, which theoretically positively draw the threads of areceptacle radially inwardly toward the thread axis when the reverseangle closure thread is torqued, provided the outer tip of the thread iscrested and strong enough, the trailing linear surface of the externalthread of the closure is angled toward the thread axis instead of awayfrom the thread axis (as in conventional v-threads). Although buttressand reverse angle threads with linear loading surfaces reduce thetendency of bone screw receiver arms to splay outwardly, the arms maystill be flexed outwardly by forces acting on the implant and thethreads can be bent and deformed by forces exerted during installation.Closures made with square threads, again, having linear loadingsurfaces, theoretically keep all forces axially directed. However, ithas been found that under a moderate load, square thread closuresproduce a marginal splay and under heavy load, splay can beconsiderable.

SUMMARY OF THE INVENTION

A closure structure embodiment according to the invention includes splaycontrol surfaces for cooperating with a bone anchor for holding a spinalfixation longitudinal connecting member, such as a rod, the anchorhaving an open receiver with spaced apart arms defining a longitudinalconnecting member receiving channel there between. Embodiments of thepresent invention provide balanced mating guide and advancement flangeforms on both a closure and cooperating spaced apart arms of the boneanchor to control splay of the arms when the closure is rotated andadvanced between the arms. Embodiments of the invention aid in splaycontrol during torquing or tightening of the closure with respect to thearms that occurs when the closure abuts against an insert located in thereceiver or directly against a longitudinal connecting member. In anillustrated embodiment, the closure flange form is located on an outerclosure member and the closure includes an inner threaded set screw. Acooperating bone anchor assembly includes a compression insert locatedbetween the closure outer member and an upper portion of a bone screwshank that is located within a cavity of the receiver. Downward pressureby the outer closure member on the compression insert causes the insertto press downwardly on the bone screw shank upper portion that in turnpresses against the receiver, locking the shank in a selected angularposition with respect to the receiver. In the illustrated embodiment,the inner set screw eventually locks a rod or other longitudinalconnecting member to the bone anchor. Although only a two piece closureis illustrated, one piece closures that press directly on a rod or othermember are possible. Thus, more generally stated, closure embodiments ofthe invention are sized for being received within the receiver channeland adapted for rotation and advancement into the channel between thearms to capture a portion of the longitudinal connecting member in thechannel and also control splay of the receiver arms during tightening ofthe closure with respect to other components of the assembly.

The closure guide and advancement flange form extends helically alongthe closure and about a central axis of the closure. A desired splaycontrol is affected by certain parameters, including but not limited toflange form thickness, flange form height, height differentials alongcertain portions of the form, pitch, angular orientation of certainsplay control contours and spatial relationships between the closureflange form and the receiver flange forms to result in axial loading onsome portions of the forms and clearance and thus lack of loading onother portions of the forms.

The general shape of a “boot” can be used to describe certain closureflange form embodiments of the invention. The “boot” has a contoured orrounded “toe” pointing rearwardly and a “heel” facing downwardly. Anupper most top surface of the “toe” remains unloaded in use.

More specifically, according to an aspect of the invention, the closureflange form includes a first portion located adjacent a root of the formand extending radially outwardly therefrom in a direction away from thecentral axis, the first portion having a first load flank surface. Theclosure flange form also has a second portion extending radiallyoutwardly from a termination of the load flank to a crest of the flangeform. The second portion includes a first splay control ramp and thecontoured or rounded toe, the toe being spaced from the load flank bothradially and axially. A radial distance defining a thickness of thefirst portion generally ranges between about forty percent to aboutsixty percent of an entire thickness of the closure flange form measuredradially from the root to the crest, but can greatly vary. In certainpreferred embodiments the flange form thickness of the first portion isabout the same as a flange form thickness of the second portion.

An angle defined by a radius running from the closure central axis andperpendicular thereto with a substantial portion of the splay controlramp is oblique. In certain instances, when a majority of the splaycontrol ramp is a radiused surface, such an angle may be defined by atangent of such radiused surface, running from the load flank.Preferably, the angle ranges between about thirty-nine and abouteighty-nine degrees.

A discontinuous receiver guide and advancement flange form extendshelically about and along an inner surface of each receiver arm, thereceiver flange form having a second load flank and a second splaycontrol ramp engaging the first load flank and the first splay controlramp during mating of the closure flange form with the receiver flangeform, the receiver flange form having clearance surfaces disposed inclose spaced relation to a remainder of the closure flange form. Thus,each of the receiver arm flange forms are not identical in shape andsize to the closure flange form or forms. Rather, a balance is createdbetween the interlocking forms, both having a same or substantiallysimilar cross-sectional area, and thus strength, to ensure engagement ofthe load flanks and splay control ramps of each of the forms. Thebalanced interlocking forms also are shaped to ensure that the topsurface of the toe portion of the closure flange form that is spacedfrom the root and extends axially upwardly is never loaded and thus thereceiver flange forms are configured to provide space or clearance atnot only stab flank or leading surfaces but also at the closure toe.Depending on initial engagement of mating splay control ramp surfaces,slopes can be controlled so that the closure flange form is able to drawin the upright arms of a receiver, which by comparison is typically theweaker of the flange form components.

Another aspect of the invention concerns the height of the closureflange form at certain locations. A closure guide and advancement flangeform embodiment includes a crest portion with a first height measuredaxially (parallel to the closure central axis) and a root portion havinga second axial height (measured parallel to the central axis), the firstheight measured from a top of an upwardly extending toe of the flangeform to a stab flank and taken substantially along a crest surface ofthe flange form, the second height measured from a load flank of theflange form to the stab flank and taken substantially along a rootsurface of the flange form, the first height being one of slightly lessand substantially equal to the second height.

The illustrated embodiment of a flange form according to the inventionis a multi-start form, specifically a dual start form and thus two splaycontrol forms are disposed on the closure structure, each having a startlocated near a bottom of the closure. It is foreseen that a single startflange form could be used in other embodiments of the invention. By wayof explanation, it is noted that the force required to press a closurestructure down onto a rod or other connector located between arms of anopen implant is considerable. Even though a head or receiver portion ofan open polyaxial bone anchor may be pivoted in a direction to make iteasier for the arms of the open implant to receive a rod or otherconnector, spinal misalignments, irregularities and the placement ofother surgical tools make it difficult to place the rod or otherconnector between the arms of the implant while a closure structure ismated with the open implant as well as used to push the rod or otherconnector downwardly into the implant. For example, when the closure isa cylindrical plug having a single start helically wound guide andadvancement structure, such structure must be aligned with matingstructure on one of the implant arms and then rotated until a portion ofthe structure is captured by mating guide and advancement structure onboth arms of the implant, all the while the closure is being presseddown on the rod while other forces are pushing and pulling the rod backout of the implant. Integral or mono-axial open implants that cannot bepivoted to receive the rod are even more difficult to manipulate duringthe initial placement of the rod and initial mating rotation of aclosure plug between the spaced, open arms of the implant. Therefore,extraordinary forces are placed on the implant and closure plug whilethe surgeon either pushes down on the rod or pulls up on the bone to getthe rod in position between the implant arms and to initially push downupon the rod with the closure plug. The double starts of the illustratedclosure provide for a more even and accurate pressing and rotation ofthe closure structure with respect to the receiver at the very beginningof the closure/receiver mating procedure, when alignment of thecomponent parts is at its most difficult.

Objects of the invention further include providing apparatus and methodsthat are easy to use and especially adapted for the intended use thereofand wherein the tools are comparatively inexpensive to produce. Otherobjects and advantages of this invention will become apparent from thefollowing description taken in conjunction with the accompanyingdrawings wherein are set forth, by way of illustration and example,certain embodiments of this invention.

The drawings constitute a part of this specification and includeexemplary embodiments of the present invention and illustrate variousobjects and features thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of a two piece closure accordingto an embodiment of the invention.

FIG. 2 is an enlarged front elevational view of the closure of FIG. 1with portions broken away to show the detail thereof.

FIG. 3 is an enlarged and fragmentary view with portions broken away ofthe closure of FIG. 2.

FIG. 4 is a reduced perspective view of the closure of FIG. 1.

FIG. 5 is a reduced top plan view of the closure of FIG. 1.

FIG. 6 is a reduced bottom plan view of the closure of FIG. 1.

FIG. 7 is a reduced front elevational view of the closure of FIG. 1,with portions broken away similar to FIG. 2 and shown in a first stageof mating engagement with an embodiment of a polyaxial bone screw havinga shank, a receiver and a lower pressure insert and further shown with arod, also shown in front elevation with portions broken away to show thedetail thereof.

FIG. 8 is another front elevational view with portions broken away ofthe assembly shown in FIG. 7, the closure being shown in initialengagement with the lower pressure insert.

FIG. 9 is an enlarged and partial front elevational view with portionsbroken away of the assembly shown in FIG. 8, illustrating contactbetween the closure top outer portion and the insert, but no loading.

FIG. 10 is a partial front elevational view with portions broken away ofthe assembly as shown in FIG. 9, but illustrating a light load beingplaced on the insert by rotation of the closure top outer portiondownwardly against the insert.

FIG. 11 is a partial front elevational view with portions broken away ofthe assembly as shown in FIG. 10, but illustrating a medium load beingplaced on the insert by further rotation and downward movement of theclosure top outer portion.

FIG. 12 is a partial front elevational view with portions broken away ofthe assembly as shown in FIG. 11, but with a high load being placed onthe insert by further rotation and downward movement of the closure topouter portion.

FIG. 13 is a partial front elevational view with portions broken away ofthe assembly as shown in FIG. 12, but with a higher load sufficient tofrictionally fix the insert against the shank head and thus the shankhead against the receiver.

FIG. 14 is a reduced and partial front elevational view with portionsbroken away of the assembly of FIG. 13 and further showing the closureinner set screw rotated and lowered into fixed, frictional engagementwith the rod.

FIG. 15 is an enlarged and fragmentary front elevational view withportions broken away of the assembly of FIG. 14.

FIG. 16 is a reduced and partial perspective view of an assembly similarto that shown in FIG. 14, differing from the assembly of FIG. 14 only inthat the shank is positioned at an angle with respect to the receiver,the rod being shown in phantom.

FIG. 17 is a front elevational view of an embodiment of an alternativesplay control closure according to the invention with portions brokenaway to show the detail thereof.

FIG. 18 is an enlarged and partial front elevational view of the closureof FIG. 17 with portions broken away to show the detail thereof.

FIG. 19 is an enlarged and partial broken-away version of anotherembodiment of a splay control closure according to the invention.

FIG. 20 is another enlarged and partial broken-away version of theclosure of FIG. 19.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments are disclosed herein; however, it isto be understood that the disclosed embodiments are merely exemplary ofthe invention, which may be embodied in various forms. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a basis for the claims and asa representative basis for teaching one skilled in the art to variouslyemploy the present invention in virtually any appropriately detailedstructure. It is also noted that any reference to the words top, bottom,up and down, and the like, in this application refers to the alignmentshown in the various drawings, as well as the normal connotationsapplied to such devices, and is not intended to restrict positioning ofthe bone attachment structures in actual use.

It is noted that the helically wound splay control flange formsdescribed in detail herein cannot be considered thread forms as flangeforms include numerous features, including surfaces and contours,compound and non-linear, in addition to and not anticipated bytraditional screw thread technology and nomenclature. However, certainterms used in this application will be similar to those used in threadform nomenclature. For example, in traditional v-thread nomenclature, aflank is often described as a thread face running from a root to a crestof a thread form with the root being the bottom surface joining flanksof two adjacent flanks and the crest being the top and bottom surfacesjoining two flanks of a single thread form near an outer edge or tipthereof. In this application, the term flank may be used to describecertain surfaces of a flange form, such as a loading or thrust surface,but unlike a thread, a flange form flank does not necessarily connect aroot to a crest of a particular form. Similarly, a crest or outermostedge surface of a flange form does not necessarily function as thesurface that joins two flanks as other features, such as splay controlsurfaces and/or unloaded curves or contours, may be located between aflank and a crest. Furthermore, while a root surface of a flange formmay typically be substantially cylindrical and a crest surface of aflange form may be at least partially cylindrical, such surface may alsobe sloped or curved. Thus, an entire outer surface which might beidentified as a “crest” surface of a closure plug may or may not be at auniform distance from a cooperating root surface.

Also, the terms lead, pitch and start, as such terms are used todescribe other helically wound guide and advancement structures, are tobe understood as follows: Lead is a distance along the axis of a closureor plug that is covered by one complete rotation (360 degrees) of theclosure with respect to a mating structure. Pitch is the distance from alocation on a crest or most outward surface of one flange form structureto the same location on the next or adjacent flange form. For example ina single-start thread-form, such as a single start, helically woundv-thread closure plug, lead and pitch are the same. Single start meansthat there is only one helically wound form wrapped around a cylindricalcore, or in the case of embodiments of closures according to the presentinvention, wrapped around a cylindrical closure plug body and thus thereis only one start structure or surface at a base or forward end of theclosure body that initially engages a mating structure on an openimplant. Each time a single start closure rotates one turn (360degrees), the closure has advanced axially by a width of one helicalflange form. Double-start means that there are two forms wrapped arounda core body and thus there are two starting surfaces or structures onthe closure plug. Therefore, each time a double-start body rotates oneturn (360 degrees), such a body has advanced axially by a width of twohelical flange forms. Multi-start means that there are at least two andmay be up to three or more of such forms wrapped around a core body.Similar to threads, flange forms may also be coarse or fine. Courseflange forms are those with a larger pitch (fewer forms per axialdistance) and fine forms have a smaller pitch (more forms per axialdistance).

Closures according to the invention may take a variety of forms,including single and multi-start options, one piece closures, two piececlosures, closures with break-off heads, for example, and may be usedwith a wide variety of medical implants, including, but not limited tomono-axial screws and hooks, hinged or uni-planar screws and hooks anddual multi-piece polyaxial bone screws and hooks, as well as screws withsliding or pivoting inserts. A variety of polyaxial bone screws may alsobe used with splay control structures of the invention and theillustrated embodiment should not be considered limiting. For example,splay control structures of the invention may be used with bone screwshaving top loaded bone screw shanks with spherical heads (such as theillustrated bone screw 1) and also with bottom-loaded multi-part screwshanks as well as bottom loaded “pop-on” screws, such as Applicant'sU.S. patent application Ser. No. 12/924,802, filed Oct. 5, 2010, forexample, that is incorporated by reference herein. In this application,an embodiment of a two-piece, dual start closure, generally 18,according to the invention is shown in FIGS. 7-16, with an open implantin the form of a polyaxial bone screw apparatus or assembly, generally 1that includes a shank 4, that further includes a body 6 integral with anupwardly extending substantially spherical upper portion or head 8; areceiver 10 having a cavity or inner chamber for receiving the shankhead 8 communicating with an upper channel formed between opposed arms11 having top surfaces 12; and a compression or pressure insert 14having a lower surface 15 engaging the shank head 8 within the receivercavity, the illustrated insert 14 also defining an inner channel betweenopposed upright arms 16, each having a top surface 17.

The illustrated closure 18 includes two pieces: an outer structure orfastener 19 having an outer guide and advancement structure in the formof a double-start helically wound splay control flange form and an innerthread sized and shaped for cooperation with a coaxial threaded innerplug 20, the helically wound forms of both of the structures 18 and 19having an axis of rotation A. The closure top 18 is illustrated alone inFIGS. 1-6 and shown with the bone screw assembly 1 in FIGS. 7-16. In theclosure illustrated in FIG. 1, the plug 20 is bottom or uploaded intothe outer structure 19. However, it is foreseen that in otherembodiments, the plug 20 may be down or top-loaded into the structure19.

As will be described in greater detail below, the outer structure 19 ofthe closure top 18 mates under rotation with the receiver 10 having acentral axis B with the axis A being aligned with the axis B, thestructure 19 pressing downwardly against the insert 14 arm top surfaces17, the insert surface 15 in turn pressing downwardly against the shankhead 8 that in turn frictionally engages the receiver 10, locking thepolyaxial mechanism of the bone anchor 1, (i.e., fixing the shank 4 at aparticular angle with respect to the receiver 10). The closure innerplug 20 ultimately frictionally engages and presses against alongitudinal connecting member, for example, a rod 21, so as to capture,and fix the longitudinal connecting member 21 within the receiver 10 andthus fix the member 21 relative to a vertebra 23. The illustrated rod 21is hard, stiff, non-elastic and cylindrical, having an outer cylindricalsurface 22. However, a longitudinal connecting member for use with theassembly 1 may take the form of an elastic or deformable rod or have adifferent cross-sectional geometry. The longitudinal connecting membermay also be a part of a soft or dynamic system that may include hard orsoft structure for attaching to the assembly 1 and may further include atensioned cord, elastic bumpers and spacers located between bone screws,for example. In the illustrated embodiment, the receiver 10 and theshank 4 cooperate in such a manner that the receiver 10 and the shank 4can be secured at any of a plurality of angles, articulations orrotational alignments relative to one another and within a selectedrange of angles both from side to side and from front to rear, to enableflexible or articulated engagement of the receiver 10 with the shank 4until both are locked or fixed relative to each other near the end of animplantation procedure.

Returning to FIGS. 1-6, the illustrated multi-start closure 18 outersplay control structure 19 has a double or dual start helically woundguide and advancement structure in the form of a pair of identicalhelically wound forms 42, each illustrated as a flange form thatoperably joins with mating flange form structure 43 disposed on the arms11 of the receiver 10 to result in an interlocking guide and advancementstructure or arrangement, generally 44 (see FIGS. 7 and 8, for example).Although one particular flange form structure and relationship,generally 44, will be described herein with respect to the forms 42 and43, it is noted that flange forms may be of a variety of geometries,including, for example, those described in Applicant's U.S. patentapplication Ser. No. 11/101,859 filed Apr. 8, 2005 (US Pub. No.2005/0182410 published Aug. 18, 2005), which is incorporated byreference herein.

Each form 42 includes a start surface or structure 46 and thus, as shownin FIG. 6, the structure 19 includes two starts 46. Each of the forms 42may be described more generically as being positioned as an inner flangeof the overall structural arrangement 44 as each form 42 extendshelically on an inner member that in the illustrated embodiment is theclosure structure 19. The flange form 43, on the other hand, extendshelically within an outer member that in the illustrated embodiment isin the form of the receiver 10 arms 11. The flanges 42 and 43 cooperateto helically guide the inner member or structure 19 into the outermember or receiver 10 when the inner member 19 is rotated and advancedinto the arms 11 of the outer member 10. The inner and outer flanges 42and 43 have respective splay regulating contours to control splay of thereceiver arms 11 when the inner member 19 is strongly torqued therein.In some embodiments of the invention the member 19 may be asubstantially solid plug that is eventually torqued against the rod 21to clamp the rod within the receiver 10. In the illustrated embodiment,the inner threaded plug 20 is the feature that ultimately clamps down onthe rod 21 and also mates with the member 19 via a v-thread that will bedescribed in greater detail below.

With particular reference to FIGS. 2, 3 and 15 each flange form 42includes several surfaces or contours that helically wrap about the axisA. The contours of the flange form 42 include a root surface 47 that ishelical and disposed substantially parallel to the axis A. A virtualcylinder formed by the root surface 47 has a radius R1 (radial distancebetween the axis A and the surface 47). Adjacent the root surface 47 isa radiused surface, curve or corner surface 48 that in turn is adjacentto a load or loading surface or flank 49. The load flank 49 is on atrailing side relative to a direction of advancement of the structure 19along the axes A when the structure 19 rotatingly mates with the flangeform 43 on the receiver arms 11. In the illustrated embodiment, inaddition to sloping helically downwardly toward the start 46, the loadflank 49 also slopes slightly downwardly in a direction running radiallyoutwardly from the root surface 47 toward an outer or crest surface 51.However, the load flank 49 does not extend all of the way to the crestsurface 51 as will be described in greater detail below. In someembodiments of the invention, the load flank 49, or at least portionsthereof, may slope more steeply with respect to the horizontal, may besubstantially horizontal (i.e., perpendicular to the axis A) or may evenslope in a slightly upward direction toward a top surface 53 of thestructure 19, i.e., reverse angle in nature. In the illustratedembodiment, the slightly downwardly sloping load flank 49 advantageouslyresults in a thicker stronger flange form 42 structure at and near theroot surface 47, giving the closure 19 a bigger bite of the cooperatingform 43 than would be possible with a horizontal load flank. Althoughthe downwardly sloping load flank 49 may actually cause an initialoutward splay of the arms 11 during rotation of the form 42 into theform 43, the downward slope provides a remainder of the flange form 42with additional clearance for drawing portions of the flange form 43 ina direction toward the structure 19 as will be described in greaterdetail below. The thickness or height of the form 42 near the root 47also provides the form 42 with adequate strength for pulling the form 43inwardly rather than relying solely on a bending moment created by aremainder of the form. With particular reference to FIG. 3, a preferredangle of slope (represented by the letter L) of the load flank 49 rangesbetween about one degree and about five degrees with respect to a radialline extending perpendicular to the axis A (illustrated as a horizontaldotted line X in FIG. 3), although other angles are possible.

With further reference to FIGS. 2 and 3, in certain embodiments, as isshown in the present illustration, a substantial portion of the crestsurface 51 is substantially parallel to the root surface 47. Thus, avirtual cylinder formed by the crest surface 51 has a radius R2 (radialdistance between the axis A and the surface 51). However, in otherembodiments, the outer or crest surface may include radiused surfaces ata top and bottom thereof and may further have other sloping portionsthat are not parallel to the root surface. Thus, although the radialmeasurements R1 and R2 are substantially uniform for the illustratedembodiment, it is noted that in other embodiments, R1 would refer to thesmallest distance from the axis A to a root surface or point 47 and R2would refer to the greatest distance between the axis A and a crestsurface or point. With further reference to FIG. 2, a distance Didentifies a depth of the flange form 42 from the crest 61 to the root47. Stated in another way, D=R2−R1. The distance or depth D may befurther broken down into D1 and D2 wherein D1 is a distance from thecrest surface 51 to the load flank 49 and D2 is a length of the loadflank 40 measured from the root surface 47 a location 54 where the loadflank 49 terminates. The distance D1 can be equal to, less than orgreater than D2. The distance or depth D2 may preferably range frombetween about forty to about sixty percent of the total distance D. In apreferred embodiment of the invention D1 is slightly less than orsubstantially equal to D2, with the total D preferably ranging betweenabout 0.65 mm and about 1.1 mm (between about 0.026 in. and about 0.043in.). A most preferred value for D ranges between about 0.70 mm andabout 0.90 mm (between about 0.028 in. and about 0.035 in.). However,flange depths or lengths D can range from about 0.2 to over 2.0 mm.

With particular reference to FIG. 3, adjacent the loading flank 49 atthe location 54 and running upwardly (in a direction toward the topsurface 53) as well as outwardly toward the crest surface 51, is a splaycontrol ramp or surface portion, generally 55 that in the illustratedembodiment includes a lower substantially frusto-conical surface 56 andan upper convex radiused surface portion 57. It is noted that althoughthe splay control ramp 55 is ultimately an “anti-splay” structure forinterlocking with the flange form 43 on the receiver arms 11,prohibiting undesirable outward splay of the arms 11 when in fulllocking engagement with the closure structure 19, it has been found thatduring torquing of the closure structure 19 with respect to the receiverarms 11, the flange form 42, and depending on geometry, even a portionof the ramp 55 may cause an outward splay in one or more surroundingcomponents, so the term “splay control” is being used herein rather thanthe term “anti-splay” for the various flange form components andcontours. It is also noted that in other embodiments of the invention,the splay control ramp may include additional contours or curves thatmay control splay either inwardly or outwardly. The loading flanksurfaces that include the load flank 49 and the splay control ramp 55are typically non-linear and compound in surface contour, the ramp 55providing splay control. In the illustrated embodiment, the radiusedsurface 57 is adjacent to another radiused surface 60 that curvesoutwardly and then downwardly, converging into the crest surface 51. Theflange form can be thought of as a “boot,” having a toe 61 and a heel62. The splay control ramp surfaces 56 and 57 and the upper rounded orradiused surface 60 define the protrusion, bead or toe 61 of the flangeform 42 that is directed generally upwardly toward the top surface 53and also outwardly away from the loading flank 49 and a downward orleading facing heel 62. As will be described in greater detail belowwith respect to the cooperating flange form 43 on the receiver arms 11,the surfaces defining the toe 61 are spaced from the load flank 49, and,unlike the load flank 49, the toe 61 is never loaded, but always spacedfrom the flange form 43 of the receiver 10. In the illustratedembodiment, the individual surfaces that lead up to the toe and make upthe toe are gradually increasing in radius. In other words, the surface60 has a radius that is greater than a radius of the surface 57 and thesurface 61 has a radius greater than the radius of the surface 60. Theillustrated heal 62 is also radiused and forms a lower corner of theflange form, the heal 62 being located adjacent the crest surface 51 ata base thereof and joining the crest surface 51 with a stab surface orflank 64. The stab flank 64 is located generally opposite the load flank49 and the toe 61. The load flank 49 may also be referred to as a thrustsurface while the stab flank 64 may also be referred to as a clearancesurface. To complete the illustrated flange form 42 geometry, a curvedsurface 66 made up of one or more radiused surface portions joins thestab surface 64 to the root surface 47.

With further reference to FIG. 2, and as described previously herein, apitch P is a distance from a point on the crest surface 51 of one flangeform to a corresponding point on the crest surface 51 of an adjacentform, the distance being measured parallel to the axis A. In theillustrated embodiment of a two-start flange form, the distance P ismeasured between two forms having different starts. It has been foundthat the smaller or finer the pitch, the greater the thrust for a giventorque. Typically, for fixed bone anchors, including polyaxialmechanisms, utilizing the flange form 42, torques range between about 75and about 125 inch pounds (between about 8.5 and about 14.1Newton-meters (Nm)). To perform well in such a torque range, flangeforms of the invention may vary more widely in pitch, for example, thepitch P may range from about 0.039 inches to about 0.120 inches, with apitch P range of about 0.045 inches to about 0.065 inches beingpreferred in embodiments having single start flanges and higher pitchesin embodiments having dual start flanges. However, even lower and higherpitches can be used.

Another measurement illustrated in FIG. 2 is a first height H1 that runsfrom an upper most point of the surface 60 defining the toe 61 (upperbeing in a direction toward the top surface 53) to an opposite or lowermost point of the curve or corner 62, measured parallel to the axis A.Another measurement is a second height H2 that is a distance from theload flank 49 the curved surface 66 that joins the stab flank 64 withthe root surface 47. The measurements H1 and H2 provides a sense ofbalance of the flange form 42 at either side of the load flank 49, withH1 preferably being slightly less than or equal to H2. The second heightH2 is preferably about equal to or even larger than the overall depth Dof the flange. Thus, a ratio of the flange form depth D over the flangesecond height H2 preferably ranges from a value less than 1 to about 1.As indicated above, a downward slope of the load flank 49 results in anH2 value of the flange form 42 near the root 47 that advantageouslyresulted in a stronger form for controlling splay than, for example, anembodiment wherein the flank 49 is horizontal (perpendicular to the axisA).

Returning to the splay control ramp 55, as illustrated in FIG. 3, thelower ramp surface 56 is shown extended (the dotted line T) and an angleR is formed by the dotted line T and a line X disposed perpendicular tothe closure axis A. In the illustrated embodiment, the angle R isapproximately sixty degrees. Preferably, the splay control ramp angle Ris less than ninety degrees, and more preferably ranges between aboutthirty and about eighty-nine degrees and even more preferably betweenabout fifty-five and about eighty-five degrees. Most preferred are splaycontrol ramps with the angle R ranging between about fifty-five andabout sixty-five degrees. Stronger splay control ramps are over seventydegrees and weaker ramps are less than seventy degrees. With respect totorque vs. thrust, allowing some controlled splay of about 0.004 to0.006 inches has been found to provide more thrust for a given torque,such as 70 to 110 inch pounds. As described above, in some embodiments,rather than being defined primarily by a frusto-conical surface, thesplay control ramp 55 may be made up of one or more radiused surfaces.In such embodiments, the dotted line T represents a tangent lineoriginating at the load flank 49 and intersecting a contoured surface orsurfaces defining a substantial portion of the splay control ramp 55.

With particular reference to FIGS. 13-15, the flange form 43 located oneach receiver arm 11 cooperates with the form 42, but is not identicalthereto or even a mirror image thereof. Rather, a balance is createdbetween the flange form 42 and the flange form 43 to provide load andclearance surfaces to result in a desired splay control of the receiverarms 11. Stated in another way, many cross-sectional shapes of the form43 are nearly the same as adjacent cooperating shapes of the form 42,thus, the forms are substantially balanced in cross-sectional area, butclearances between certain surfaces are important, for example, the form43 must always be spaced from surfaces making up the unloaded toe 61,and engagement by other surfaces is important, for example, the form 43must engage, touch or slide upon, the form load flank 49 and splaycontrol ramp 55. Finally, to minimize stress risers, corners of the twoflange forms 42 and 43 must be radiused.

With specific reference to FIG. 15, the flange form 43 includes a loadflank 79 and a crest surface 81. A radiused corner surface 82 connectsthe flank 79 and the crest surface 81. At an opposite side of the loadflank 79 a radiused surface 84 joins the flank 79 with a splay controlramp 85. The splay control ramp 85 terminates at a location 87 that isadjacent a clearance surface 88 that extends inwardly toward the rootsurface 77. Another radiused surface 89 connects the clearance surface88 with the root surface 77. At an opposite side of the root surface 77,another radiused corner surface 90 connects the root surface 77 with astab flank or surface 94. To complete the geometry of the flange form43, a radiused corner surface 95 connects the stab flank 94 with thecrest surface 81. In FIG. 15, the flange form 43 load flank 79 is shownfrictionally engaging the closure form 42 load flank 49. Unlike theclosure form 42 that does not engage the form 43 and thus is neverloaded, the load flank 79 located on the receiver arms 11 primarilydefines an engaged, loaded toe 97 of the form 43. Thus, although theflange form 42 looks very much like the flange form 43, similargeometric forms do not perform similarly. As is also shown in FIG. 15,the splay control ramp 85 of the flange form 43 engages the splaycontrol ramp 55 of the flange form 42 when the closure structure 19 ismated and torqued into tight locking engagement with the form 43 on thereceiver arms 11. A step-by-step observance of the cooperation betweenthe forms 42 and 43 during mating engagement will be described belowwith respect to FIGS. 9-13. The root surface 77 of the form 43 is alwaysspaced from the crest surface 51 of the form 42 and the crest surface 81of the form 43 is always spaced from the root surface 47 of the form 42during rotation and locking of the closure structure 19 with respect tothe receiver arms 11. As stated previously, the toe 61 of the closureflange form 42 is always unloaded, thus the splay control ramp 85 of theflange form 43 is sized such that the termination location 87 of theramp 85 is always spaced from the form 42 toe surfaces 57 and 60.Likewise, the clearance surface 88 and corner surface 89 of the form 43are sized and contoured to clear the form 42 toe surface 60 as well asthe crest surface 51. In the illustrated embodiment, with reference toFIG. 15, a height H3 of the toe portion of the closure flange formmeasured from the termination 54 of the flank surface 49 to a top of thesurface 60 is greater than a clearance C3 measured between the closurestab surface 64 and the receiver stab flank 94.

In general, the load flanks 49 and 79 are positively engaged and axiallyloaded, that is, loaded in the direction of the axis A, when the closuremember 19 is advanced into the receiver arms 11. As relative torquebetween the inner closure member 19 and the outer member arms 11increases, by engagement with the insert 14 of the illustratedembodiment, for example, and in other embodiments by engagement with aclamped member such as the rod 21, there is a tendency for the arms 11,to splay outwardly away from the axis A. At such time, the splay controlramps 55 and 85 mutually engage in a radial direction to interconnectand mechanically lock, resisting the splay tendency of the receiver arms11. Thus, relative torque between the inner and outer members 19 and 11can be much higher in comparison to conventional V-threads or guide andadvancement structures which do not have splay control contours, therebyallowing a considerably higher, more positive clamping force to beapplied to the closure 19 and ultimately to the rod 21 by the inner setscrew 20 as will be described in greater detail below.

Prior to describing the use of the closure 18 with respect to the boneanchor 1 as shown in FIGS. 7-16, other features of the closure 18 shownin FIGS. 1-6 shall be described. With particular reference to FIG. 1, anexploded view of the nested closure structure or closure top 18 thatincludes the outer fastener structure 19 and the uploaded inner setscrew 20 is shown. It is noted that anti-splay structure of theinvention may also be utilized on single-piece cylindrical plug-likeclosures as well as on other types of one and two piece nested closures,for example, those having a break-off head that separates from theclosure when installation torque exceeds a selected level, such as theclosures disclosed in Applicant's U.S. Pat. No. 7,967,850 (see, e.g.,FIGS. 22-25 and accompanying disclosure), that is incorporated byreference herein. The illustrated fastener stricture 19 further includesa through-bore 104 extending along the axis A and running completelythrough the fastener 18 from the top surface 53 to a bottom surface 106.The bottom surface 106 is substantially planar and annular andconfigured for being received between the receiver arms 11 and forexclusively abutting against the substantially planar top surfaces 17 ofthe insert arms 16, the insert 14 arms 16 being configured to extendabove the rod 21 such that the closure surface 106 is always spaced fromthe rod 21 or other longitudinal connecting member portion received bythe insert arms 16 and located within the receiver 10.

As indicated previously, the closure or fastener structure 19 issubstantially cylindrical and the two flange forms 42 projectsubstantially radially outwardly. The closure structure 18 helicallywound flange form 42 start structures 46 are located on opposite sidesof the closure structure and are both located adjacent the bottomsurface 106. When the closure structure 19 is rotated into the receiver10 between receiver arms 11, each having the flange form 43 guide andadvancement structure, the start 46 engages mating guide and advancementstructure 43 on one arm 11 and the opposite start 46 simultaneouslyengages guide and advancement structure flange form 43 on the opposingarm 11, both forms 42 being simultaneously captured by the mating forms43 on the opposed arms 11. As the structure 19 is rotated, the structureadvances axially downwardly between the arms 11 and presses evenly downupon the insert 14 arm top surfaces 17. Each time the illustrated duel-or double-start closure plug 19 is rotated one complete turn or pass(three hundred sixty degrees) between the implant arms, the closure 19advances axially into the receiver 10 and toward the insert 14 by awidth of two helical flange forms. The closure 19 is sized for at leastone complete rotation (three hundred sixty degree) of the closure 19with respect to the receiver 10 open arms 11 to substantially receivethe closure 18 between the implant arms. Multi-start closures of theinvention may have two or more coarse or fine helical forms, resultingin fewer or greater forms per axial distance spiraling about the closureplug body and thus resulting in plugs that rotate less or more than onecomplete rotation to be fully received between the implant arms.Preferably, helically wound forms of the multi-start closure of theinvention are sized so as to spiral around a cylindrical plug bodythereof to an extent that the closure rotates at least ninety-onedegrees to fully or substantially receive the closure 19 between thearms of the bone screw receiver or other open implant. Particularlypreferred guide and advancement structures are sized for at least onecomplete turn or pass (three-hundred sixty degree) of the closurebetween the receiver 10 arms 11 and as many as two to three rotations tobe fully received between implant arms.

Returning to FIGS. 1 and 2, at the closure structure base or bottomsurface 106 and running to near the top surface 53, the bore 104 issubstantially defined by a guide and advancement structure shown in thedrawing figures as an internal V-shaped thread 110. The thread 110 issized and shaped to receive the threaded set screw 20 therein as will bediscussed in more detail below. Although a traditional V-shaped thread110 is shown, it is foreseen that other types of helical guide andadvancement structures may be used. Adjacent the closure top surface 53,the bore 104 is defined by a cylindrical surface 112 that runs from thetop surface 53 to the v-thread 110. The cylindrical surface has a radiusmeasured from the axis A that is the same or substantially similar to aradius from the axis A to a crest 114 the v-thread 110. In theillustrated embodiment, a distance from the top surface 53 to thev-thread 110 measured along the surface 112 is greater than a pitch ofthe v-thread, the surface 112 acting as a stop for the inner set screwor plug 20, preventing the screw 20 from rotating upwardly and out ofthe structure 19 at the top surface 53. However, it is foreseen that thesurface 112 may be taller or shorter than shown, and that in someembodiments, a radially inwardly extending overhang or shoulder may belocated adjacent the top surface 53 to act as a stop for the set screw20. In other embodiments, the set screw 20 may be equipped with anoutwardly extending abutment feature near a base thereof, withcomplimentary alterations made in the fastener 19, such that the setscrew 20 would be prohibited from advancing upwardly out of the top ofthe structure 19 due to abutment of such outwardly extending feature ofthe set screw against a surface of the fastener 19. In otherembodiments, the central set screw may be rotated or screwed completelythrough the outer ring member.

With particular reference to FIGS. 4 and 5, formed in the top surface 53of the fastener 19 is a cross-slotted internal drive, made up of threespaced cross-slots, or stated in other way, six equally spaced radialslots 116. An upper portion 118 of each slot 116 extends from the bore104 radially outwardly to the flange form 42 root surface 47 and thuscompletely through the top surface 53 of the structure 19, each upperportion 118 being adjacent the cylindrical surface 112 along an entireheight thereof. Another, lower portion 119 of each slot 116 extendsdownwardly below the cylindrical surface 112 and cuts into the v-thread110, terminating at a substantially planar base surface 121 and beingpartially defined by a cylindrical wall 123. The cross-slotted driveslots or grooves 116 are advantageous in torque sensitive applications:the more slots, the greater the torque sensitivity. Further, the slotlower portions 119 provide additional surfaces 121 and 123 for grippingby a cooperating drive tool (not shown) sized and shaped to be receivedby the slot lower portions 119.

The up-loadable set screw 20 has a substantially annular and planar top126 and a substantially circular planar bottom 127. The screw 20 issubstantially cylindrical in shape and coaxial with the fastener 18. Thescrew 20 is substantially cylindrical and includes an upper outercylindrical surface 130 adjacent a v-thread surface portion 132 that inturn is adjacent to a lower frusto-conical surface 134 that runs to thebase or bottom surface 127. The cylindrical surface 130 is sized andshaped to be received by the inner cylindrical surface 112 of the outerfastener 19. The v-thread 132 is sized and shaped to be received by andmated with the inner thread 110 of the fastener 19 in a nested, coaxialrelationship. The frusto-conical surface 134 is sized and shaped toclear the insert 14 arms 16 are exclusively press upon the rod 21 asshown, for example, in FIG. 14.

As illustrated, for example, in FIGS. 2 and 5, the set screw 20 includesa central aperture or internal drive feature 140 formed in the top 126and sized and shaped for a positive, non-slip engagement by a set screwinstallment and removal tool (not shown) that may be inserted throughthe bore 104 of the fastener 19 and then into the drive aperture 140.The drive aperture 140 is a poly drive, specifically, having ahexa-lobular geometry formed by a substantially cylindrical wall 142communicating with equally spaced radially outwardly extending (from theaxis A) rounded cutouts or lobes 144. The wall 142 and the lobes 144terminate at a substantially planar driving tool seating surface 146.Although the hexa-lobular drive feature 140 is preferred for torquesensitive applications as the lobes are able to receive increased torquetransfer as compared to other drive systems, it is noted that otherdrive systems may be used, for example, a simple hex drive, star-shapeddrive or other internal drives such as slotted, tri-wing, spanner, twoor more apertures of various shapes, and the like. With particularreference to FIGS. 1 and 2, the central set screw aperture 140cooperates with the central internal bore 104 of the fastener 19 foraccessing and uploading the set screw 20 into the fastener 19 prior toengagement with the bone screw receiver 10. After the closure structure19 is inserted and rotated into the flange form 43 of the bone screwreceiver 10, the set screw 20 is rotated by a tool engaging the drivefeature 140 to place the set screw bottom 127 into frictional engagementwith the rod 21 or other longitudinal connecting member. Such frictionalengagement is therefore readily controllable by a surgeon so that therod 21 may be readily manipulated until late in the surgery, if desired.Thus, at any desired time, the set screw 20 may be rotated to drive thescrew 20 into fixed frictional engagement with the rod 21 withoutvarying the angular relationship between the receiver 10 and the bonescrew shank 4.

It is foreseen that the set screw 20 may further include a cannulationthrough bore extending along a central axis thereof for providing apassage through the closure 18 interior for a length of wire (not shown)inserted therein to provide a guide for insertion of the closure topinto the receiver arms 11. The base 27 of the screw 20 may furtherinclude a rim for engagement and penetration into the surface 22 of therod 21 in certain embodiments of the invention.

When the closure 18 is used with a bone anchor 1 as shown in the drawingfigures, preferably, the receiver 10 and the compression insert 14 ofthe bone screw 1 are assembled at a factory setting that includestooling for holding, alignment and manipulation of the component pieces,as well as crimping a portion of the receiver 10 toward the insert 14.In the illustrated embodiment, the shank 4 is also assembled with thereceiver 10 and the insert 14 at the factory. In other bone screwembodiments, for example when the bone screw shank is a bottom loaded“pop-on” screw, such as described, for example, in applicant's U.S.patent application Ser. No. 12/924,802 that has already beenincorporated by reference herein, it may be desirable to first implantthe shank, followed by addition of a pre-assembled receiver andcompression insert (and other components, such as a retaining ring) atthe insertion point. In this way, the surgeon may advantageously andmore easily implant and manipulate the shanks, distract or compress thevertebrae with the shanks and work around the shank upper portions orheads without the cooperating receivers being in the way. In otherinstances, including non-pop-on top loaded bone screw shank embodiments,it may be desirable for the surgical staff to pre-assemble a shank of adesired size and/or variety (e.g., surface treatment or roughening theshank upper portion and/or hydroxyapatite on the shank body), with thereceiver and compression insert. Allowing the surgeon to choose theappropriately sized or treated shank advantageously reduces inventoryrequirements, thus reducing overall cost.

As illustrated in FIG. 7, the entire assembly 1 made up of the assembledshank 4, receiver 10 and compression insert 14, is screwed into a bone,such as the vertebra 23, by rotation of the shank 4 using a suitabledriving tool (not shown) that operably drives and rotates the shank body6 by engagement thereof at an internal drive thereof. Specifically, thevertebra 23 may be pre-drilled to minimize stressing the bone and have aguide wire (not shown) inserted therein to provide a guide for theplacement and angle of the shank 4 with respect to the vertebra. Afurther tap hole may be made using a tap with the guide wire as a guide.Then, the assembly 1 is threaded onto the guide wire utilizing acannulation bore of the shank 4. The shank 4 is then driven into thevertebra 23 using the wire as a placement guide. It is foreseen that theshank and other bone screw assembly parts, the rod 21 (also having acentral lumen in some embodiments) and a variation of the closure top 18having a central through bore could be inserted in a percutaneous orminimally invasive surgical manner, utilizing guide wires.

Again, with reference to FIG. 7, the rod 21 is eventually positioned inan open or percutaneous manner in cooperation with the at least two bonescrew assemblies 1. The closure structure 18 made up of the outerfastener 19 and the inner set screw 20 (already mated with the fastenerthread 110) is then inserted into the receiver arms 11 at the top 12thereof and the fastener is advanced by rotation between the arms 11 ofeach of the receivers 10 at the flange form two starts 46 as previouslydescribed herein.

With reference to FIGS. 8 and 9, the closure structure 19 is rotated,using a tool engaged with the drive slots 116 until the structure 19bottom surface 17 engages the insert arm top surfaces 17. Then, withreference to FIGS. 10-13, the structure 19 is rotated until a selectedtorque is reached. For example, about 80 to about 120 inch pounds oftorque on the closure structure 19 may be applied for fixing the insert14 against the bone screw head 8 that in turn fixes the head 8 withrespect to the receiver 10.

With particular reference to FIGS. 9-13, FIG. 9 is an enlarged andpartial view of the assembly as shown in FIG. 8, showing the closure 19rotated to an initial position wherein the closure bottom surface 17 isengaging the insert arms 16 at the top surfaces 17 thereof, but nototherwise pressing downwardly on the insert 14. Thus, there is minimalor almost zero pressure or load in the axial direction (with referenceto the axis A) between the load flank 49 of the dual closure forms 42 onthe fastener 19 and the load flank 79 of the receiver forms 43 locatedon each arm 11. Furthermore, as can be seen in FIG. 9, there is a gapbetween the splay control ramps 55 of the forms 42 of the closure 19 andthe splay control ramps 85 of the forms 43.

With reference to FIG. 10, further rotation of the fastener 19 withrespect to the receiver arms 11 that produces a light load on the flanks49 and 79, results in some splay of the insert 14 as indicated by theinitial gap between the insert arm 16 and the flange form 43 crestsurface 81 indicated by the reference numeral 81A located below thefastener 19 in FIG. 9 as compared to the insert arm 16 touching thecrest surface at the location 81A in FIG. 10.

When a medium load is placed on the form 43 by further rotation of theform 42 as shown in FIG. 11, the receiver arms 11 begin to splayoutwardly. This is evident, for example, by looking at a space betweenthe flange form 42 crest surface 51 at a location 51A and the flangeform 43 root surface 77 at a location 77A in FIG. 10 as compared to awider space between the forms at the locations 51A and 77A in FIG. 11.

As the load increases further as shown in FIG. 12, the outward splayingof the receiver arms 11 increases slightly and the load flanks 79 of thearm flange forms 43 raise up off of the load flanks 49 of the closure19. The rotation of the fastener flange forms 42 with respect to the armflange forms 43 causes an upward and outward sliding movement of thesplay control ramp 85 along the splay control ramps 55.

With reference to FIGS. 13 and 15, final tightening and torque betweenthe flange forms 42 and 43 causes the flange form 42 to pull inwardly onthe flange form 43, reducing the outward splay and resulting in fullyengaged loading flanks 55 and 85. Any further outward splay of the arms16 of the insert 14 is also prohibited by the receiver arms 11 that nowpress inwardly on the insert 14 as evidenced by the lack of gap betweenthe insert arm 16 and the flange form 43 crest surface 81 at thelocation 81A as compared to the slight gap shown at the location 81A inFIG. 12. As is shown in FIGS. 9-13, during tightening of the closurestructure 19 into the receiver arms 11, there is a push/pullrelationship between the closure 19 flange forms 42 and the receiverforms 43. Initially, the closure 19 body and the flange form structuredefined by the slightly downwardly sloping load flank 49, push outwardlyon the receiver arms 11. However, as the form 42 is rotated within acooperating form 43, the initial expansion or splay of the arms 11provides surfaces and contours for the control ramp surfaces 55 to gripand draw back in a direction toward the axis A. It is noted thatthroughout the tightening, torquing process, the toe 61 of the flangeform 42 is never loaded and always spaced from surfaces of the flangeform 43.

With reference to FIG. 14, the inner set screw 20 is then rotated, usinga tool engaged with the drive feature 140 until the set screw bottomsurface 127 presses the rod 21 into full frictional engagement with theinsert 14. As shown in FIG. 14, during tightening of the set screw 20against the rod surface 22, there is no measurable outward splay of thereceiver arms 11 as the flange forms 42 of the outer fastener 19 are ingripping interlocking engagement with the flange forms 43 on thereceiver arms. If adjustment of the rod 21 is desired, the inner setscrew 20 may be rotated in an opposite direction, loosening the rod 21,but not the locked polyaxial mechanism created by the outer fastener 19pressing downwardly upon the insert 14 that in turn locks the bone screwshank 4 with respect to the receiver 10. If, however, removal of the rodis necessary, disassembly is accomplished by using the driving tool (notshown) that mates with the internal drive slots 116 on the closurestructure 19 to rotate and remove such closure structure from thecooperating receiver 10. Disassembly is then accomplished in reverseorder to the procedure described previously herein for assembly.

With reference to FIG. 16, prior to locking the insert 14 against theshank head 8, the shank 4 may be pivoted to a plurality of potentiallydesirable positions with respect to the receiver 10, followed by lockingof the polyaxial mechanism by fully mating the multi-start closure top19 with the receiver 10, followed by locking the rod in place with theset screw 20.

With reference to FIGS. 17 and 18, an alternative two-start closure ofan embodiment of the invention, generally 218, is illustrated having alower substantially cylindrical plug or body 230 and an upper integralbreak-off head 232. The body 230 includes an outer helically woundflange form guide and advancement structure 242 (dual start) thatoperably joins with the guide and advancement flange form structure 43disposed on the arms of the receiver 10 or other receiver structure. Itis foreseen that the dual-start closure guide and advancement structure242 could alternatively be in the form of a buttress thread, a squarethread, a reverse angle thread or other thread-like or non-thread-likehelically wound advancement structure, for operably guiding underrotation and advancing the closure 218 downward between the receiver 10or other receiver arms and having such a nature as to resist splaying ofthe arms when the closure 218 is advanced into the receiver channel. Asshown in FIG. 17, the illustrated closure structure 218 also includesthe break-off head 232 having a hex shape sized and shaped forcooperation with a socket-type tool. The head 232 is designed to breakfrom the body 230 of the closure at a preselected torque, for example,70 to 140 inch pounds. The closure body 230 includes a top surface 244and an internal drive 246 formed therein that defines an aperture and isillustrated as a star-shape, such as that sold under the trademark TORX,or may be, for example, a hex drive or other internal drives such asslotted, tri-wing, spanner, two or more apertures of various shapes, andthe like. A driving tool (not shown) sized and shaped for engagementwith the internal drive 246 may be used for both rotatable disengagementof the closure 218 from the receiver arms, and re-engagement, ifrequired. A base or bottom surface 247 of the closure is planar andfurther includes a central dome or nub 248 for gripping of a rod (eitherpressing directly downwardly on a rod or orienting a smaller rod towardone side of a compression insert) or for pressing into a deformable rod.In other embodiments, closure tops may include central points and/orspaced outer rims for engagement and penetration into rod or otherlongitudinal connecting member outer surfaces. It is noted that in someembodiments, the closure bottom surface does not include a nub, point,or rim. In some embodiments, the closure may further include acannulation through bore extending along a central axis thereof, openingat the drive feature and extending through the bottom surfaces thereof.Such a through bore provides a passage through the closure interior fora length of wire (not shown) inserted therein to provide a guide forinsertion of the closure top into the receiver arms.

With particular reference to FIG. 18, it is noted that the illustratedflange form structure 242 is a dual start structure that has a flangeform depth D′ measured from a root to a crest of the flange form 242 ofbetween about 0.7 and about 0.8 millimeters. The flange form structure242 further has a pitch P′ (axial distance between flange forms, forexample, as shown in FIG. 17 of about 0.100 inches. Returning to FIG.18, the flange form structure 242 also has a splay control ramp surface256 (shown extended as a line T′ in phantom) that is disposed at anangle R′ of about eighty degrees with respect to a radius or referenceline X′ perpendicular to a central axis of the closure 218. It is notedthat with such a geometry, particularly with such a large pitch, adesirable material for the closure structure 218 is a cobalt chromealloy so as to counter possible loosening that may occur under cyclicalloading. If the structure 218 is made from cobalt chrome, a desirablematerial for a cooperating receiver is less hard than cobalt chrome, forexample, stainless steel, titanium or a titanium alloy.

With reference to FIG. 19, another flange form arrangement according toan embodiment of the invention is shown having a closure 18′ with a maleflange form structure 42′ and a receiver 10′ with a female closurestructure 43′. Although not necessarily identical, the structures 42′and 43′ have surfaces that function similarly to respective structures42 and 43 and thus similar surface will be identified by the samereference numeral and a “ ” will be added for identification purposes inthis application. Thus, similar to the previously discussed structures42 and 43, each flange form 42′ includes several surfaces or contoursthat helically wrap about a central axis of the closure 18′, forexample, similar to the closure shown in FIG. 1. The contours of theflange form 42′ include a root surface 47′ that is helical and disposedsubstantially parallel to the closure central axis. Similar to thesurface 47 described previously herein, the surface 47′ may beunderstood as defining a virtual cylinder formed by a minor radius ofthe closure (radial distance between the closure central axis and thesurface 47′). Adjacent the root surface 47′ is a radiused surface, curveor corner surface 48′ that in turn is adjacent to a load or loadingsurface or flank 49′. The flange form 42′ further includes a splaycontrol ramp 55′ and an upper rounded or radiused surface 60′.Similarly, with respect to the cooperating female or receiver flangeform 43′, such form includes a load flank 79′, a crest surface 81′, aradiused corner surface 82′, an opposed radiused surface 84′ and a splaycontrol ramp 85′. It is noted, that in operation, because of theradiused surface 48′ of the flange form 42′ and the receiver flange formradiused surface 82′, an operational root location 47″ is defined thatis spaced outwardly radially from the surface 47′ and is a firstlocation wherein the cooperating flange form loading surfaces or flanks49′ and 79′ can engage. A height H2′ of the flange form 42′ is definedas an axial height of such flange form located along the operationalroot 47″. Similarly, the female or receiver flange form 43′ has a heightHH2′ defined as an axial height of the form 43′ located along anoperational root 77″ that is located radially inwardly of a root surface77′ of the flange form 43′. With further reference to FIG. 19, CMAidentifies a major flange clearance and CMI identifies a minor flangeclearance created by the cooperating radiused surfaces of the flangeforms 42′ and 43′. In the embodiment illustrated in FIG. 19, loading ofthe flange forms at surfaces 49′ and 79′ advantageously occurs at orsubstantially near the root 47″ of the male or closure flange form 42′.Even during controlled splay of the form 43′ (similar to what is shownand described with respect to FIGS. 9-13), loading of the flange forms42′ and 43′ remains as close as possible to the male (closure)rootlocation 47″. A flange depth D′ is also shown in FIG. 19 that shows aflange thickness taken between radiused surfaces that define clearancesbetween the flange forms 42′ and 43′. An axial distance or pitch P′ isalso shown in FIG. 19. FIG. 19 illustrates a ratio of D′ to H2′ (D′/H2′)of less than 1. Such ratio is also shown in the enlarged FIG. 20 thatfurther includes exemplary measurements for various parameters of thecooperating flange forms 42′ and 43′. Such measurements are for exampleonly and should not be considered as limiting the invention in anymanner.

It is noted that as compared to conventional thread forms, even during atime of splay, contact between the loading surfaces 49′ and 79′ occursand remains substantially near the operational root 47″. In contrast ina square thread closure, for example, as splay occurs, overlapping ofloading surfaces decreases and migrates until failure occurs. Also, witha square thread form, splay is not ultimately constrained by a splaycontrol ramp as illustrated and described herein with respect toclosures of the invention. Thus, in embodiments of the invention, splayis allowed and then ultimately constrained. This allows for a maximumthrust or downward force of the closure 18 or 18′ against a rod for agiven amount of torque. Flange forms according to embodiments of theinvention also advantageously redirect splay forces diametrically acrossthe closure 18 or 18′, converting bending moment to tension, pullingopposed arms of the receiver (or receiver extension portions) toward oneanother during rotation of the closure between the receiver arms.

It is to be understood that while certain forms of the present inventionhave been illustrated and described herein, it is not to be limited tothe specific forms or arrangement of parts described and shown.

What is claimed and desired to be secured by Letters Patent is asfollows:
 1. A spinal fixation assembly comprising: a receiver having aset of arms, each of the arms having a lower inner surface and anextension portion, each extension portion having an upper inner surfaceextending above the lower inner surface; a channel defined by the set ofarms and the extension portions; a closure top rotationally receivableand advanceable downwardly into the channel; a closure top flangeextending continuously and helically about the closure top, the closuretop flange having a closure top load flank surface and a closure topsplay control ramp; and a receiver flange extending discontinuously andhelically along the lower and upper inner surfaces of each of thereceiver arms and extension portions, respectively, the receiver flangehaving a receiver load flank surface and a receiver splay control ramp,the closure top flange and the receiver flange allowing an outward splayof the receiver arms and the extension portions, as a torque between theclosure top and the receiver set of arms increases during loading of theclosure top load flank and the receiver load flank surfaces so as toprovide more thrust for a given amount of torque while moving a portionof a rod positioned within the channel downward along a portion of thechannel by rotational advancement of the closure top in the channel, thereceiver splay control ramp then being mutually engageable with theclosure top splay control ramp in an interlocking arrangement so as toconstrain the outward splay of the receiver set of arms when the portionof the rod is moved along the channel toward a bottom of the channel bythe rotational advancement of the closure top; wherein the closure topand receiver flanges allow an outward splay of the set of arms so as toprovide for a maximum thrust for a given amount of torque applied to theclosure top when the closure top is rotationally received and advanceddownwardly into the receiver channel and the amount of torque rangesbetween 70 in pounds and 125 in pounds.
 2. The spinal fixation assemblyof claim 1, wherein the closure top flange includes a termination at alower end of the closure top comprising at least one start structurewith a leading face.
 3. The spinal fixation assembly of claim 2, whereinthe closure top flange has a first flange with a first start structureat the termination thereof and a second flange with a second startstructure at the termination thereof, the first start structure and thesecond start structure being diametrically opposite each other andlocated adjacent the lower end of the closure top.
 4. The spinalfixation assembly of claim 2, wherein the leading face includes aconcave surface portion adjacent a root of the flange and a convexsurface portion adjacent a crest of the flange.
 5. The spinal fixationassembly of claim 4, wherein the leading face on the at least one startstructure includes a portion of a planar surface oriented obliquely withrespect to a radial line extending perpendicular from a central axis ofthe closure top through the at least one start structure between theconcave surface portion and the convex surface portion.
 6. The spinalfixation assembly of claim 4, wherein the concave and convex surfaceportion each have a radius of curvature less than a radius of curvaturefor an outer surface along the crest on the closure top flange.
 7. Thespinal fixation assembly of claim 4, wherein the closure top flangeconcave surface portion has a first radius of curvature and the convexsurface portion has a second radius of curvature substantially equal tothe first radius of curvature.
 8. The spinal fixation assembly of claim1, wherein the receiver includes a lower pressure rod-engaging insert.9. The spinal fixation assembly of claim 1, wherein the closure topincludes a closed inner threaded bore configured to engage an outerthread of a set screw.
 10. The spinal fixation assembly of claim 1,wherein the closure top flange includes a lower leading surface in thedirection of the closure top rotational advancement and an oppositeupper trailing surface having the load flank surface, the entire lowerleading surface being spaced apart from the receiver when the assemblyis in a locked orientation.
 11. The spinal fixation assembly of claim 1,wherein a portion of the closure top splay control ramp remains unloadedand spaced from the receiver flange during the rotational advancement ofthe closure top within the channel when the torque is applied to theclosure top to generate a thrust.
 12. The spinal fixation assembly ofclaim 1, wherein a toe of the closure top splay control ramp remainsunloaded and spaced apart from the receiver flange.
 13. The spinalfixation assembly of claim 1, wherein the closure top is at least oneof: a one piece closure receivable into the channel or a two piececlosure including an outer closure top member and an inner set screwreceivable into the channel.
 14. The spinal fixation assembly of claim13, wherein the closure top flange includes at least one of a singlelead flange with a single start structure or a multi-lead flange withmultiple start structures.
 15. The spinal fixation assembly of claim 13,wherein the closure top is the two piece closure including the outerclosure top member and the inner set screw, wherein the outer closuretop member includes a bottom surface configured to engage an insertdisposed in the channel of the receiver, the set screw having a solidclosed off bottom surface configured to engage the rod positioned withinthe channel of the receiver, the set screw including an internal drivesocket with a lower tool abutment surface located near the bottomsurface than a top surface on the set screw.
 16. The spinal fixationassembly of claim 1, wherein the closure top includes a breakoff head.17. The spinal fixation assembly of claim 1, wherein the closure topflange includes a downward facing surface opposite an upward facingsurface having the load flank surface, the entire downward facingsurface being spaced apart from the receiver when the assembly is in alocked orientation.
 18. The spinal fixation assembly of claim 1, whereinan angle defined by a radius running perpendicularly from a central axisof the closure top and at least a portion of the closure top splaycontrol ramp ranges between thirty and eight-nine degrees.
 19. Thespinal fixation assembly of claim 1, wherein an angle defined by aradius running perpendicularly from a central axis of the closure topand a tangent to at least a portion of the closure top splay controlramp ranges between thirty and eight-nine degrees.
 20. The spinalfixation assembly of claim 1, wherein an angle defined by a radiusrunning perpendicularly from a central axis of the closure top and atleast a portion of the closure top splay control ramp is greater thanseventy degrees.
 21. The spinal fixation assembly of claim 1, wherein anangle defined by a radius running perpendicularly from a central axis ofthe closure top and a tangent to at least a portion of the closure topsplay control ramp is greater than seventy degrees.
 22. The spinalfixation assembly of claim 1, wherein an angle defined by a radiusrunning perpendicularly from a central axis of the closure top and atleast a portion of the closure top splay control ramp is less thanseventy degrees.
 23. The spinal fixation assembly of claim 1, wherein anangle defined by a radius running perpendicularly from a central axis ofthe closure top and tangent to at least a portion of the closure topsplay control ramp is less than seventy degrees.
 24. The spinal fixationassembly of claim 1, wherein the closure top flange has a pitch rangingfrom 0.039 inches and 0.120 inches.
 25. The spinal fixation assembly ofclaim 1, wherein the closure top flange has a pitch ranging from 0.045inches and 0.065 inches.
 26. The spinal fixation assembly of claim 1,wherein each of the receiver set of arms has an outer surface, eachouter surface having a horizontal and radiused tool attachment grooveextending from a front side surface to a back side surface on thereceiver set of arms, each groove positioned below a top side surface oneach of the receiver set of arms and the extensions portions.
 27. Thespinal fixation assembly of claim 1, wherein the assembly furthercomprises at least one of a pivotal bone anchor, a pivotal bone screw, apolyaxial bone screw, a fixed bone screw, or a hook.
 28. The spinalfixation assembly of claim 1, wherein the closure top directly engagesthe portion of the rod positioned within the channel.
 29. The spinalfixation assembly of claim 1, wherein a tool is used to insert theclosure top, the tool extending at least partially through a centralaperture formed entirely through the closure top from a top side surfaceto a bottom side surface thereof.
 30. The spinal fixation assembly ofclaim 1, wherein the extension portion having the upper inner surface isremovable from each receiver arm lower inner surface.
 31. A spinalfixation assembly comprising: a closure top having a flange extendingcontinuously and helically about the closure top, the closure top flangehaving a closure top load flank surface and a closure top splay controlramp; a receiver having opposed upright arms each with a lower innersurface and an extension portion, each extension portion having an upperinner surface extending above the lower inner surface, the upright armsand extension portions defining a rod-receiving channel therebetween,the receiver upright arm and extension portion inner surfaces eachhaving a receiver flange extending discontinuously and helically alongthe inner surfaces, the receiver flange having a receiver load flanksurface and a receiver splay control ramp; the closure top beingrotationally receivable and advanceable in a downwardly direction intothe channel via engagement between the closure top flange and thereceiver flange, the receiver upright arms and extension portionsconfigured to splay outwardly with respect to each other duringrotational advancement of the closure top therebetween; the closure topflange and the receiver flange allowing an outward splay of the uprightarms and extension portions as torque between the closure top, theextension portions and the upright arms increases during loading of theclosure top load flank surface and the receiver load flank surface so asto provide more thrust for a given amount of torque while moving aportion of a rod positioned within the channel above a channel bottomsurface downward along a portion of the channel by the rotationaladvancement of the closure top in the channel, the receiver splaycontrol ramp mutually engaging the closure top splay control ramp in aninterlocking arrangement so as to constrain the outward splay of thereceiver extension portions and upright arms when the portion of the rodis moved along the channel toward the channel bottom surface by therotational advancement of the closure top; wherein the closure top andreceiver flanges allow an outward splay of the set of arms so as toprovide for a maximum thrust for a given amount of torque applied to theclosure top when the closure top is rotationally received and advanceddownwardly into the receiver channel and the amount of torque rangesbetween 70 in pounds and 125 in pounds.
 32. The spinal fixation assemblyof claim 31, wherein the extension portion is removable from thereceiver upright arms.